Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
80 participants
INTERVENTIONAL
2018-06-30
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DEP-Ru
doxorubicin (doxorubicin hydrochloride liposome injection) 25 mg/m2 day 1; etoposide 100 mg/m2 was administered day1; methylprednisolone 2 mg/kg days 1 to 5,then gradually reduce; ruxolitinib 0.3mg/kg/d。This regimen was repeated after 2 weeks.
DEP-Ru
* Drug: ruxolitinib
* Drug: doxorubicin
* Drug: etoposide
* Drug: methylprednisolone
Interventions
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DEP-Ru
* Drug: ruxolitinib
* Drug: doxorubicin
* Drug: etoposide
* Drug: methylprednisolone
Eligibility Criteria
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Inclusion Criteria
2. treated with HLH-94 no less than 2 weeks before enrollment and did not achieve at least PR; or relapsed patients after remission；
3. Life expectancy exceeds 1 month;
4. Age≥1 year old and ≤70 years old, gender is not limited；
5. Before the start of the study, total bilirubin ≤ 10 times the upper limit of normal; serum creatinine ≤ 1.5 times normal；
6. Serum HIV antigen or antibody negative；
7. HCV antibody is negative, or HCV antibody is positive, but HCV RNA is negative；
8. Both HBV surface antigen and HBV core antibody were negative. If any of the above is positive, peripheral blood hepatitis B virus DNA titer should be detected, and less than 1×103 copies/ml can enter the group；
9. Echocardiographic examination of LVEF ≥ 50%;
10. Informed consent.
Exclusion Criteria
2. Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2；
3. Pregnancy or lactating Women；
4. Allergic to Pegaspargase, doxorubicin or etoposide；
5. Active bleeding of the internal organs；
6. uncontrollable infection；
7. Serious mental illness;
8. Non-melanoma skin cancer history;
9. Patients unable to comply during the trial and/or follow-up phase;
10. Participate in other clinical research at the same time.
1 Year
70 Years
ALL
No
Sponsors
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Beijing Friendship Hospital
OTHER
Responsible Party
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Zhao Wang
Clinical Professor
Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Broglie L, Pommert L, Rao S, Thakar M, Phelan R, Margolis D, Talano J. Ruxolitinib for treatment of refractory hemophagocytic lymphohistiocytosis. Blood Adv. 2017 Aug 17;1(19):1533-1536. doi: 10.1182/bloodadvances.2017007526. eCollection 2017 Aug 22.
Wang Y, Huang W, Hu L, Cen X, Li L, Wang J, Shen J, Wei N, Wang Z. Multicenter study of combination DEP regimen as a salvage therapy for adult refractory hemophagocytic lymphohistiocytosis. Blood. 2015 Nov 5;126(19):2186-92. doi: 10.1182/blood-2015-05-644914. Epub 2015 Aug 19.
Wang J, Zhang R, Wu X, Li F, Yang H, Liu L, Guo H, Zhang X, Mai H, Li H, Wang Z. Ruxolitinib-combined doxorubicin-etoposide-methylprednisolone regimen as a salvage therapy for refractory/relapsed haemophagocytic lymphohistiocytosis: a single-arm, multicentre, phase 2 trial. Br J Haematol. 2021 May;193(4):761-768. doi: 10.1111/bjh.17331. Epub 2021 Feb 9.
Other Identifiers
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DEP-Ru HLH
Identifier Type: -
Identifier Source: org_study_id
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